TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

XYOSTED (AUTOINJECTOR)

TESTOSTERONE ENANTHATE
Oncology Approved 2018-09-28
1
Indication
--
Phase 3 Trials
7
Years on Market

Details

Status
Prescription
First Approved
2018-09-28
Routes
SUBCUTANEOUS
Dosage Forms
SOLUTION

Companies

Active Ingredient: TESTOSTERONE ENANTHATE

XYOSTED (AUTOINJECTOR) Approval History

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What XYOSTED (AUTOINJECTOR) Treats

6 indications

XYOSTED (AUTOINJECTOR) is approved for 6 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypogonadism
  • Cryptorchidism
  • Torsion
  • Orchitis
  • Vanishing Testis Syndrome
  • Delayed Puberty
Source: FDA Label

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

XYOSTED (AUTOINJECTOR) FDA Label Details

Pro

Indications & Usage

FDA Label (PDF)

Males Testosterone enanthate injection is indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired) โ€“ Testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy. Hypogonadotropic hypogonadism (congenital or acquired) โ€“ Gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. (Appropriate adrenal cortical and thyroid hormone replacement therapy are still n...

XYOSTED (AUTOINJECTOR) Patents & Exclusivity

Latest Patent: Aug 2038

Patents (207 active)

US10646495 Expires Aug 30, 2038
US9950125 Expires Sep 4, 2036
US9744302 Expires Nov 19, 2035
US11191908 Expires Oct 18, 2035
US11813435 Expires Feb 25, 2035
US10912782 Expires Feb 19, 2035
US10238662 Expires Feb 19, 2035
US11160751 Expires Oct 7, 2034
US10881798 Expires Feb 11, 2034
US11844804 Expires Jun 4, 2033
+ 197 more patents
Source: FDA Orange Book

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.